A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors

Exclusion Criteria

• •1. Within 14 days prior to the first dose: Have undergone plasmapheresis, treated with prednisone at \> 10 mg/day for \> 3 consecutive days or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory medication (Those who have received short-term treatment with such medications for the prevention of contrast media allergy may be enrolled).
• •2. Have received systemic antineoplastic therapy or investigational product treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose, have received radiotherapy within 14 days prior to the first dose.
• •3. Have received monoclonal antibody treatment within 30 days prior to the first dose.
• •4. History of solid organ transplantation.
• •5. Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (in Phase Ia clinical study only).
• •6. Presence of meningeal or brain metastases.
• •7. Evidence of cardiovascular risk, including any of the following:
• •1. QTcF interval ≥ 470 msec (QT interval must be corrected for heart rate using the Fridericia formula \[QTcF\]).
• •2. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular (AV) block.
• •3. Within 6 months before screening, history of myocardial infarct, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty or stent implantation, or bypass grafting.
• •4. Class III or IV heart failure - as defined by the New York Heart Association Functional Classification.
• •5. Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
• •8. Have dyspnea or any current condition that needs continuous oxygen therapy, or current active pneumonia or interstitial lung diseases (except mild cases as judged by the investigator).
• •9. History of other primary malignancies, except for the following: malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast.
• •10. Have severe unhealed wound, ulceration or bone fracture, or have received major surgery within 28 days prior to administration or expected major surgery during the clinical study.
• •11. Prior history of allergy to any component or excipient of DXC008.
• •12. Active hepatitis B with HBV-DNA greater than central upper limit of normal or greater than 1000 copies/mL, active hepatitis C (Hepatitis C virus antibody positive with HCV RNA greater than lower limit of detection value).
• •13. Known to be seropositive for the HIV; have active syphilis (only patients with a positive syphilis antibody are eligible for enrollment in the study), possible presence of active tuberculosis (chest imaging within 3 months prior to the first dose indicates active tuberculosis infection).
• •14. Patients with active bleeding within 30 days before screening, or, judged by the investigator, to be at risk of massive digestive tract hemorrhage, hemoptysis, etc.; or with hereditary bleeding tendency or coagulation disorder, or bleeding symptoms requiring other medical intervention.
• •15. Have experienced serious arterial/venous thrombosis events within 6 months prior to the first dose, such as cerebrovascular accident (including transient cerebral ischemic attack), deep venous thrombosis, pulmonary embolism.
• •16. Female subjects with positive serum pregnancy test or who are breastfeeding.
• •17. Those with active infection requiring drug intervention (CTCAE ≥ Grade 2) within 2 weeks prior to the first dose of study treatment, uncontrollable pleural effusion, ascites, pericardial effusion requiring repeated drainage.
• •18. Have received vaccination with live attenuated vaccine within 28 days prior to the first dose or planned to receive such vaccination during the study period.
• •19. Patients with other conditions judged by the investigator that may have adverse effect on the patient's participation in the study.